N/A
Completed N=45
KOSO (Keep On Stepping On)/ Stepping Online
Fall Related Injury · Social Isolation
Source: ClinicalTrials.gov NCT02774889 ↗
Enrolled (actual)
45
Serious AEs
0.0%
Results posted
Jan 2022
Primary outcomePrimary: Change of Number of Falls From Baseline to 6 Months — 0.28; 0.40 falls — p=0.55
Summary
The overall purpose of this multi-phase study is to develop (Phase 1) and test potential effectiveness and feasibility of Keep On Stepping On (KOSO)/Stepping Online, an online falls prevention maintenance program for Stepping On (SO) graduates in a group randomized trial (Phase 2).
This application refers to effectiveness component of Phase 2, which entails the randomized clinical trial. Phase 1 has been completed. The feasibility component of Phase 2 will entail process evaluation of the Stepping Online intervention group only.
Outcome Measures
| Outcome | Result | p-value |
|---|---|---|
| PRIMARY Change of Number of Falls From Baseline to 6 Months |
0.28; 0.40 | 0.55 |
| SECONDARY Number of Tandem Walk Errors at 3 Months and 6 Months |
4.55; 2.62; 2.10; 6.84; 2.41; 6.48 | 0.001 sig |
| SECONDARY Gait Speed at 3 Months and 6 Months |
0.79; 0.83; 0.87; 0.79; 0.89; 0.75 | 0.05 |
| SECONDARY Short Physical Performance Battery (SPPB): Total Balance Test |
2.65; 2.32; 2.60; 2.57; 2.59; 2.64 | 0.88 |
| SECONDARY Short Physical Performance Battery (SPPB): Gait Speed Test |
3.09; 3.18; 3.25; 3.07; 3.46; 3.12 | 0.36 |
| SECONDARY Short Physical Performance Battery (SPPB): Chair Stand Test |
2.26; 2.41; 2.14; 1.93; 2.51; 2.24 | 0.52 |
| SECONDARY Short Physical Performance Battery (SPPB): Summary Score |
8.00; 7.91; 7.97; 7.58; 8.55; 8.01 | 0.43 |
| SECONDARY Falls Behavioral Risk Scale (FaB) |
2.73; 2.62; 2.93; 2.68; 2.72; 2.92 | 0.16 |
| SECONDARY Revised UCLA Loneliness Scale (R-UCLA) |
4.30; 4.48; 4.28; 4.37; 4.30; 4.11 | — |
| SECONDARY T-Score for Quality of Life Measured by PROMIS Global Mental Health (GMH) Instrument |
46.89; 47.58; 47.12; 47.26; 46.61; 46.94 | 0.91 |
| SECONDARY T-Score for Quality of Life Measured by PROMIS Global Physical Health (GPH) Instrument |
42.41; 43.31; 43.40; 42.77; 43.95; 42.76 | 0.54 |
| SECONDARY Physical Activity Barriers Self-Efficacy Score |
6.66; 6.43; 5.33; 5.38; 5.47; 5.57 | — |
| SECONDARY Global Rating of Change Score at 6 Months |
4.29; 2.40; 4.05; 2.30; 3.76; 1.90 | 0.04 sig |
| SECONDARY Balance Exercise Adherence at 3 and 6 Months |
4.15; 2.53; 2.91; 1.90 | 0.003 sig |
| SECONDARY Strength Exercise Adherence at 3 and 6 Months |
3.17; 2.11; 2.40; 1.64 | 0.01 sig |
| SECONDARY Social Bonding Score at 3 Months and 6 Months |
12.83; 12.57; 14.07; 13.05; 13.52; 10.92 | 0.38 |
| SECONDARY Encouragement to do Exercises Score at 3 Months and 6 Months |
3.61; 3.29; 3.34; 2.72 | 0.33 |
| SECONDARY Activities Balance Confidence (ABC) Scale at 3 and 6 Months |
7.44; 7.63; 7.76; 7.13; 7.65; 7.48 | 0.06 |
Eligibility Criteria
List of Inclusion Criteria:
- Leader/Peer Leader: Leading a SO workshop in Dane, Milwaukee, Rock, Adams, Green Lake, Marquette or Waushara counties during the timeframe prior to the 6-month trial.
- Stepping On Participants/Graduates: Enrolled in one of the above SO workshops.
In Milwaukee and Dane counties, extra effort will be made to enroll African American Stepping On participants/graduates, who are more likely to have lower income and educational level and to be uninsured than their White counterparts.
List of Exclusion Criteria:
- Leaders/Peer Leaders:
- Not available to participate in Stepping Online for more than 4 weeks out of the 6 months following enrollment
- Not in the area at the end of the 6-month trial.
- Stepping On Participants/Graduates:
- Unable participate in Stepping Online for more than 4 weeks out of the 6 months following enrollment
- Not assessed to be safe by SO leader to do the online exercise program; not in the area for the 3 month and 6 month evaluations
Data sourced from ClinicalTrials.gov (NCT02774889). Outcome figures and adverse-event rates are extracted automatically from the registry's posted results and are provided for clinician reference, not as a substitute for the primary publication. Informational only — not medical advice.